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Post Info TOPIC: Sovaldi (sofosbuvir) - Full Prescribing Information


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RE: Sovaldi (sofosbuvir) - Full Prescribing Information
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Thanks! I have failed a study using the BMS700 before - I am wondering if I am eligible for this medication.



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John   non-responder  

Undetected at week 2 on solvaldi/rib/interferon:  stayed through week 12 but virus came back as soon as I stopped.  on   Harvoni and ribravirin 24 weeks undetected after two. 8/2/15  12 week EOT  UNDETECTED!  SVR

1991-2015 RIP

 



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Hi Jill,

Thanks for this.

I don't like the fact that Gilead have set such firm parameters for the management of the Riba anaemia. The statement 'Reduce Ribavirin to 600 mg/day if Hb falls to <10 g/dL, and discontinue Riba if Hb drops to <8.5 g/dL' seems extreme.  In the highly litiginous USA, this ties the hands of the Hepatologist.  Many patients can manage with a Hb of <10, and why does the Riba reduction have to be so large?  Procrit is an accepted management of anaemia, but this is not mentioned. The Victrelis and Incivek Prescribing Information leaves this up to the Hepatologist to manage.

The section about resistant mutations is confusing. They describe only one relapser who had the S282T RAV. The other substitutions mentioned have been discussed and discounted by other researchers. I think there's a lot they either don't know, or are keeping to themselves.

I can't understand why Stopping Rules are not discussed. Does Gilead want to make sure every patient gets at least 12 weeks of Sovaldi? Cheers.



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Geno 1b, IL28B CT,  x3 prior relapser,  ex-cirrhotic, 74 yo, did 48 weeks with Victrelis/Peg./Riba.  VL 1.28m at start, UNDET. at 8 ,12 ,16 ,24 ,30  and 48 weeks.  EOT 15 Feb 2013 , UNDET. at EOT + 28 weeks. SVR!  Still Undet. at EOT +4 years

Malcolm



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Sovaldi (sofosbuvir) - Full Prescribing Information, from Gilead Sciences.

Pdf format...

http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/sovaldi/sovaldi_pi.pdf



__________________

Jill 

(68 yo, lives in UK)

Was Gen 3a, 

24wks Peg/Riba, Sep 2010 - Mch 2011

UND @ Wk.4, UND @ EOT, 

SVR Nov 2011 --> Still UND @ EOT + 4 yrs.

 

 

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